Treats Parkinson’s disease 1.1 Parkinson's Disease. ANDA 202786, held by Alembic. Ropinirole Hydrochloride.
As of Nov 15, 2026, ANDA 202786 (Ropinirole Hydrochloride), held by Alembic, was first approved by FDA on Apr 22, 2013, with 3 approved supplements and 0 published complete response letters.
Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease 1.1 Parkinson's Disease
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 22, 2013 | Original application | Approved | None posted |
| Ropinirole HydrochlorideEQ 2MG BASE · tablet, extended release;oral | Ropinirole Hydrochloride | Rx |
| Ropinirole HydrochlorideEQ 4MG BASE · tablet, extended release;oral | Ropinirole Hydrochloride | Rx |
| Ropinirole HydrochlorideEQ 6MG BASE · tablet, extended release;oral | Ropinirole Hydrochloride | Rx |
| Ropinirole HydrochlorideEQ 8MG BASE · tablet, extended release;oral | Ropinirole Hydrochloride | Rx |
| Ropinirole HydrochlorideEQ 12MG BASE · tablet, extended release;oral | Ropinirole Hydrochloride | Rx |
| Nov 19, 2025 | Supplement 21Labeling · Standard review | Approved | None posted |
| Jan 10, 2016 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 10, 2016 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 22, 2013 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
